{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2008
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "OTHER",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "1823260-2008-01651",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080218",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K953239",
      "date_of_event": "20080114",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "report_date": "20080122",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "HEALTH PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Health Professional",
        "User facility"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20080122",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080429",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080218",
          "brand_name": "MODULAR ANALYTICS CORE",
          "generic_name": "CLINICAL CHEMISTRY ANALYZER - JJE",
          "manufacturer_d_name": "ROCHE DIAGNOSTICS",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "INDIANAPOLIS",
          "manufacturer_d_state": "IN",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "MODULAR CORE",
          "catalog_number": "03329771001",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "JJE",
          "device_age_text": "NA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.2160",
            "device_class": "1"
          }
        }
      ],
      "product_problems": [
        "High Test Results"
      ],
      "reporter_state_code": "KY",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250814",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20080218",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "UNK",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unknown (for use when the patient's condition is not known)"
          ]
        },
        {
          "patient_sequence_number": "2",
          "date_received": "20080218",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": ""
        },
        {
          "patient_sequence_number": "3",
          "date_received": "20080218",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": ""
        },
        {
          "patient_sequence_number": "4",
          "date_received": "20080218",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": ""
        }
      ],
      "distributor_city": "",
      "date_report": "20080218",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1000775",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080122",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "781906",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008, WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 1, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED."
        },
        {
          "mdr_text_key": "6075986",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "3",
          "text": "USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008 WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 3, INITIAL GAVE 34 MMOL/L; REPEAT GAVE 27 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED."
        },
        {
          "mdr_text_key": "6078100",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "2",
          "text": "USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008 WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 2, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED."
        },
        {
          "mdr_text_key": "6320014",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "4",
          "text": "USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008 WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 4, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}